At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 54 enrolled

Drug / intervention

Abiraterone acetate +2 moredrug

Likely dose

Abiraterone acetate 250 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00473512

NCT00473512Phase 2Completed

Compare CT.gov

A Phase I/II Open Label Study of the 17α-Hydroxylase/ C17,20 Lyase Inhibitor, Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy

Cougar Biotechnology, Inc.·interventional·Posted May 15, 2007·Updated Mar 27, 2014

In Brief

A Phase 2 clinical trial evaluating Abiraterone acetate, Abiraterone acetate MTD, and 1 other intervention for Prostatic Neoplasms. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProstatic Neoplasms

CountriesUnited Kingdom

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2005

First PostedMay 2007

Primary CompletionNov 2008

TodayJul 2026

First PostedMay 15, 2007

Enrollment StartNov 1, 2005

Primary CompletionNov 1, 2008

TodayJul 2, 2026

Enrollment to primary: 3 yearsPosted 19.1 years ago

Interventions

Abiraterone acetatedrug

Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.

Abiraterone acetate MTDdrug

Abiraterone acetate MTD orally for 12 cycles (28 day each).

Dexamethasonedrug

Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.